Otonomy OTO-313 — Treatment of Tinnitus

[Sentinel]

I really hope that this would be the first drug to treat tinnitus. In my point of view it seems promising.

@Sentinel, I hope you are still getting better? How is your tinnitus lately? Do you see any further improvement?

In short, yes.

I've developed a low and intermittent dial tone/refrigerator noise in my right (affected and treated) ear that waxes and wanes, much as my initial left ear conductive tinnitus did a year ago before it went away. The new tone is virtually inaudible in normal environments and I only occasionally hear it. The doctor who did my trial told me that my previously diagnosed ETD that caused the left in was actually Otosclerosis and not the former. 10-15% of people who have Otosclerosis end up with it only in one ear, and I only have very, very mild conductive losses there. My guess is that this new tone is likely a permutation of that. Go figure. I may do the surgery to correct it but that's down the road.

On the whole, the grating tonal shit in my right ear that used to grace my senses that I set out to vanquish or decrease has been replaced by a degraded hiss/static noise that vacillates occasionally to something tonal when I'm stressed, don't sleep, or some random anomalous thing happens. It always without fail goes back to the sort of new baseline. It has decreased in intensity and volume from the pre-injection point. Even when it spikes or goes up, I can always tell that it stays within a sort of preset range almost. Even the spikes are within their own range usually. It's given me the space to move on in a lot of ways from the trauma and distress this caused and allowed me to reconstitute my life for the better. I went through a period of very bad suffering which was not positive but I built my life back from the ground up and I'm moving in a more positive direction as a result.

TL;DR:

It's improved a great deal and stayed that way.

 

[Nobody19]

While Sentinel's testimony warms my heart, remember that this is just one anecdotal situation. It gives us no assurance that this drug will succeed.

 

[Philip83]

While Sentinel's testimony warms my heart, remember that this is just one anecdotal situation. It gives us no assurance that this drug will succeed.

True, but these numbers are not insignificant as far as I can tell. Or am I missing something? Yes, it's only in a cohort of people that have had tinnitus for less than a year, but still.

 

[Nobody19]

True, but these numbers are not insignificant as far as I can tell. Or am I missing something? Yes, it's only in a cohort of people that have had tinnitus for less than a year, but still.

Everything looked great for Frequency's trial, until it failed quite bad.

OTO-313 will only prove to help after a successful Phase 3 trial.

 

[Wrfortiscue]

Everything looked great for Frequency's trial, until it failed quite bad.

OTO-313 will only prove to help after a successful Phase 3 trial.

Only one way to find out lol. Don't poop on OTO-313 until it actually fails.

 

[UHPTS]

Everything looked great for Frequency's trial, until it failed quite bad.

No it didn't.

 

[Philip83]

Everything looked great for Frequency's trial, until it failed quite bad.

OTO-313 will only prove to help after a successful Phase 3 trial.

It didn't really look that great though. Nowhere near as good as these numbers data-wise.

 

[JuliaLang]

Hi everyone! I was invited to a pre-screening appointment for the OTO-313 trial based on the data I gave them over the phone and recent audiograms. It does not mean that I will officially be participating in the trial here in SoCal just yet, but it's a first step.

Quick stats: 33/F, tinnitus in left ear since 1/4/2021, mild to moderate, triggered by lack of sleep, hormones.

I came to this thread and was horrified to learn @ChrisBoyMonkey had such a bad experience (tinnitus got louder and spread to both ears after injection). But then I also read about @Sentinel's positive experience. So what gives?

Did we ever find out if Chris got the drug or the placebo. I did see in the trials data that placebo recipients had worse side effects and outcomes. It's so crazy but I just read a pop science book on the placebo mechanism and what we know, and it makes sense... The human mind and body are truly bizarre.

Anyway, reading about Chris' experience, I am now scared to trigger the nocebo response, aka expect a bad outcome and then that actually happens. That stuff is as real as placebo. And I also had a bad reaction to the COVID-19 vaccine this year, so I really don't know where I stand with regard to medical interventions at this point. I want to help advance science and I want to help myself, but reading such a negative account (without being able to find out if it was actually the drug that caused it or not), I am leaning toward playing it safe and canceling my appointment next week on 12/29/2021.

Please help me think this through and please let me know if you have any additional info. Feeling very conflicted. Thanks!

 

[Diesel]

Hi everyone! I was invited to a pre-screening appointment for the OTO-313 trial based on the data I gave them over the phone and recent audiograms. It does not mean that I will officially be participating in the trial here in SoCal just yet, but it's a first step.

Quick stats: 33/F, tinnitus in left ear since 1/4/2021, mild to moderate, triggered by lack of sleep, hormones.

I came to this thread and was horrified to learn @ChrisBoyMonkey had such a bad experience (tinnitus got louder and spread to both ears after injection). But then I also read about @Sentinel's positive experience. So what gives?

Did we ever find out if Chris got the drug or the placebo. I did see in the trials data that placebo recipients had worse side effects and outcomes. It's so crazy but I just read a pop science book on the placebo mechanism and what we know, and it makes sense... The human mind and body are truly bizarre.

Anyway, reading about Chris' experience, I am now scared to trigger the nocebo response, aka expect a bad outcome and then that actually happens. That stuff is as real as placebo. And I also had a bad reaction to the COVID-19 vaccine this year, so I really don't know where I stand with regard to medical interventions at this point. I want to help advance science and I want to help myself, but reading such a negative account (without being able to find out if it was actually the drug that caused it or not), I am leaning toward playing it safe and canceling my appointment next week on 12/29/2021.

Please help me think this through and please let me know if you have any additional info. Feeling very conflicted. Thanks!

Do not proceed with participating.

 

[JuliaLang]

Thanks @Diesel! What makes you say so specifically. Sorry, it's just helpful for me to discuss it with folks who "get it", vs. my super well-intentioned husband.

 

[Gb3]

@JuliaLang, I don't think your type of tinnitus would be helped by this drug.

 

[JuliaLang]

@Gb3, are you implying because it's been almost exactly a year? I am def at the cut off for this trial.

 

[Gb3]

@Gb3, are you implying because it's been almost exactly a year? I am def at the cut off for this trial.

No. It doesn't seem that your tinnitus is of cochlear origin.

 

[Diesel]

Thanks @Diesel! What makes you say so specifically. Sorry, it's just helpful for me to discuss it with folks who "get it", vs. my super well-intentioned husband.

It doesn't sound like your reason for getting tinnitus would meet the inclusion criteria. Plus, with all due respect, you seem to be very anxious about the potential outcome of getting drug/placebo. If you're not truly prepared to experience negative side effects from the placebo or drug, it will affect the trial.

 

[Piney]

Hi everyone! I was invited to a pre-screening appointment for the OTO-313 trial based on the data I gave them over the phone and recent audiograms. It does not mean that I will officially be participating in the trial here in SoCal just yet, but it's a first step.

Quick stats: 33/F, tinnitus in left ear since 1/4/2021, mild to moderate, triggered by lack of sleep, hormones.

I came to this thread and was horrified to learn @ChrisBoyMonkey had such a bad experience (tinnitus got louder and spread to both ears after injection). But then I also read about @Sentinel's positive experience. So what gives?

Did we ever find out if Chris got the drug or the placebo. I did see in the trials data that placebo recipients had worse side effects and outcomes. It's so crazy but I just read a pop science book on the placebo mechanism and what we know, and it makes sense... The human mind and body are truly bizarre.

Anyway, reading about Chris' experience, I am now scared to trigger the nocebo response, aka expect a bad outcome and then that actually happens. That stuff is as real as placebo. And I also had a bad reaction to the COVID-19 vaccine this year, so I really don't know where I stand with regard to medical interventions at this point. I want to help advance science and I want to help myself, but reading such a negative account (without being able to find out if it was actually the drug that caused it or not), I am leaning toward playing it safe and canceling my appointment next week on 12/29/2021.

Please help me think this through and please let me know if you have any additional info. Feeling very conflicted. Thanks!

If you have hearing loss on that side and tinnitus that bothers you enough; it wouldn't be a question. You would already be ready in the parking lot for the shot. The choice is yours and the trial team alone.

 

[JuliaLang]

@Diesel, you are right and since I just read a book on placebo and nocebo, I hear you (no pun intended). I think the criteria is for them to decide, from what I know I had a viral episode but there's a history of noise exposure as well. I gave them all this info via email and phone and was invited to come in. As mentioned I did send over my audiogram that shows hearing loss in both ears but worse in the ringing/left ear.

 

[DebInAustralia]

No. It doesn't seem that your tinnitus is of cochlear origin.

How is it determined if tinnitus is of cochlea origin?

 

[Gb3]

How is it determined if tinnitus is of cochlea origin?

Hearing loss or acoustic trauma. Something like TMJ would not be of cochlear origin.

 

[Alberte]

Julia, do you decide to go the pre-screening appointment? If you have questions and are worry, ask them all your questions.

 

[Taw]

Hearing loss or acoustic trauma. Something like TMJ would not be of cochlear origin.

I have both TMJ and acoustic trauma, but the tinnitus increased after the acoustic trauma, of course.

 

[Kenilworth]

Otonomy Reports Corporate and Product Pipeline Update
Multiple clinical trial readouts for OTO-313 in tinnitus and OTO-413 in hearing loss expected during 2022

Just saw this a moment ago. Thought I should share.

 

[Brian Newman]

Thanks, good find. They seem confident as hell. I think Otonomy has a good chance with their drugs getting to market.

 

[NYCGuy]

Seems good progress from them! Also finally trying a higher dose.

 

[Taw]

Hopefully it will work for also hyperacusis, not just for tinnitus.

 

[Survivor234]

They're also finally trying out the drug on bilateral tinnitus sufferers:

Additional efficacy results from the Phase 2 extended observation period and safety data from the bilateral and higher unilateral dose study are anticipated in the second half of 2022.

 

[Wrfortiscue]

Hopefully it will work for also hyperacusis, not just for tinnitus.

One can only hope.

 

[NYCGuy]

OTO-313 are expected to support an End-of-Phase 2 meeting with the FDA and inform the design of the Phase 3 clinical program planned to start in the first half of 2023.

Does this mean thus far the results from Phase 2 are so good that they are already planning on Phase 3? That gives me a lot of hope.

 

[Bambam0]

Otonomy Reports Corporate and Product Pipeline Update
Multiple clinical trial readouts for OTO-313 in tinnitus and OTO-413 in hearing loss expected during 2022

Just saw this a moment ago. Thought I should share.

This is amazing news lol.

 

[Eliot Martin]

This is amazing news lol.

Let's all hope it works.

 

[hopes]

They don't know the results for Phase 2 yet. It's double blinded.